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Terminated

Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 4 boxes are placed into one shipping carton/case.

FDA Recall Z-0573-03 · Posted 2003-02-25

Recalling FirmDynarex Corporation
Recall StatusTerminated
Product CodeFXX
Date Initiated2002-12-31
Date Terminated2012-08-30
Product Quantity396 cases (50 masks per box, 4 boxes per case)

Reason for Recall

Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.

Root Cause

Other

Distribution Pattern

Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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